Sep 8
How to get the most out of medical device user testing
Do you know the most overlooked step in creating a useful medical device?
It might sound surprising, but if we were to look at a graveyard of failed products, more often than not they fail because, while they deliver their promise, they fail the user. Do not underestimate how critical it is to seek user feedback in the design process. User feedback is essential for making educated design decisions.
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When I joined StarFish Medical I was pretty stoked about the 3D printer and marvelled at the prints created by the Mechanical Engineers and Industrial Designers. As a Human Factors Engineer in product development my favorite challenges are the ones that call on imaginative solutions for investigating and testing use-related ideas and concepts for new products.
Co-op students answer FAQs and share their experiences
The design process is all about making design decisions. Whether the outcome is good or bad, the faster you can validate these decisions, the better your design becomes because you are iterating and learning. My new favorite tool to iterate is our laser cutting machine.
On June 26, 2022, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) released the Government response to consultation on the future regulation of medical devices in the United Kingdom. This response will effectively guide the UK’s post-Brexit implementation plan for medical device regulation. The following are high-level key points that are sure to be of interest to medical device manufacturers. 
Smart phones build a digital profile by tracking and monitoring our behavior and activities. Digitalization is happening all around us and COVID-19 has brought even more digital technologies into our lives. It is encouraging to see how data is being integrated into health care systems.
Many organizations have struggled to comply with ISO 13485 and FDA regulations because the FDA did not formally recognize the ISO 13485 standard in their regulations. Now, the FDA is taking a step forward to incorporate ISO 13485 into their Part 820. This will potentially reduce the confusion manufacturers have experienced in the past.
Editor’s note: This is the 2022 update to the August 2015 “5 Tips for medical device cyber security” blog by Vincent Crabtree. Read the original one 
Still wondering what to do on your summer vacation. We asked StarFish Medical employees to share their bucket list vacation activities. It’s four years and a pandemic since our first 
I could spend a lot of time trying to make sure my medical device project plan is useful. But most effective proof for me is hearing this phrase: “Hey Doug, I was looking at the plan…”.
My goal as a medical device development program manager is to save time while managing risk. I save time by reinforcing a concept you likely apply every day, but might not use in your medical device development project.